Levoxine: Product Information

LEVOXINE- levothyroxine sodium powder
First Priority Incorporated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

A Palatable Supplement for the Correction of Conditions Associated with Hypothyroidism in Horses and Ponies.

WARNING: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For Animal Use Only • Keep Out of Reach of Children

INDICATIONS:

For use in horses and ponies for correction of conditions associated with low circulating thyroid hormone (hypothyrodism).

DOSAGE:

Doses should be individualized and animals should be monitored daily for clincial signs of hyperthyroidism or hypersensitivity. Suggested initial doses are 1-10 mg levothyroxine sodium (T₄ )/100 lb body weight (2-20 mg/100 kg) once per day or in divided doses. Response to the administration of Levoxine^™ Powder should be evaluated clinically every week until an adequate maintenance dose is established. In most horses, this is usually in the range of 35 to 100 mg total daily dose of T₄ (1-3 level tablespoonfuls Levoxine^™ Powder).

INGREDIENTS:

Each pound (453.6 g) contains:

Levothyroxine Sodium USP …………………………………. 0.22% (1.0 g)

One level teaspoonful contains 12 mg of T₄ : one level tablespoonful contains 36 mg of T₄ .

WARNING: Administer with caution to animals with clincially significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous. Use in pregnant mares has not been evaluated.

STORAGE: Store at controlled room temperature between 15° — 30°C (59° — 86°F). Keep container tightly closed when not in use.

USE ONLY AS DIRECTED

Net Contents:

1 lb (453.6 grams), Reorder No. NS190PC

10 lb (4.5 kg), Reorder No. NS191PC

USE ONLY AS DIRECTED

Made in U.S.A.

Manufactured By:

First Priority, Inc., Elgin, IL 60123

www.prioritycare.com

NOT RETURNABLE IF OUTDATED

1.0 lb (453.6 g) jar

10 lb (4.5 kg) pail

LEVOXINE levoxine powder

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58829-278 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 1000 mg in 453.6 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58829-278-16 453.6 g in 1 JAR None 2 NDC:58829-278-07 4500 g in 1 PAIL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2008

Labeler — First Priority Incorporated (179925722)

Registrant — First Priority Incorporated (179925722)

Establishment
Name	Address	ID/FEI	Operations
First Priority Incorporated		179925722	manufacture

Revised: 09/2018 First Priority Incorporated